A Long-Term Safety Study Evaluating the Safety and Systemic Exposure of AR-15512 (COMET-4)

Aerie Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Dry Eye Disease

Treatments: Drug: 0.003% AR-15512 ophthalmic solution; Drug: AR-15512 vehicle ophthalmic solution

Study type: Interventional

Funder types: Industry

Identifiers

NCT05493111

AR-15512-LTSS

Details and patient eligibility

About

The purpose of this study is to evaluate the safety of topical ophthalmic 0.003% AR-15512 compared to its vehicle dosed twice daily (BID) in subjects with dry eye disease (DED) for 12 months.

Full description

At the end of the Screening Visit, subjects will undergo a protocol-specified washout period for prohibited prior and concomitant therapies. At the Baseline Visit, subjects who qualify based on inclusion/exclusion criteria will be enrolled in the study and randomized in a 2:1 ratio to receive 0.003% AR-15512 or AR-15512 Vehicle administered as 1 drop in each eye twice a day for 365 days (12 months). At the end of the Day 365 visit, subjects will exit the study.

Aerie Pharmaceuticals was acquired by Alcon on November 22, 2022.

Enrollment: 275 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Key Inclusion Criteria:

• Previous history of Dry Eye Disease (DED) within the previous 12 months of the Baseline visit.
• Have used or desired to use artificial tears for DED symptoms within 3 months prior to the Baseline visit.
• Corrected visual acuity as specified in the protocol at the Baseline visit.
• Good general and ocular health, as determined by the investigator using medical history, ophthalmic examination and history, and vital signs (heart rate and blood pressure) at the Baseline visit.

Key Exclusion Criteria:

• History or presence of any ocular disorder or condition (other than DED) in either eye that would, in the opinion of the investigator, likely interfere with the interpretation of the study results or subject safety.
• Current evidence of other significant ophthalmic disease requiring topical medication (e.g. glaucoma, ocular hypertension) which may interfere with vision (e.g., cataract, macular degeneration) or other disease which the investigator believes may interfere with study findings or interpretation.
• Use of contact lenses in either eye within 7 days prior to the Baseline visit or planned use during the study.
• Use of medications as specified in the protocol.
• Use of lid heating therapy (i.e., LipiFlow®, iLUX®) or Meibomian gland probing/therapeutic expression within 6 months prior to the Baseline visit or anticipated during the study.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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275 participants in 2 patient groups, including a placebo group

0.003% AR-15512

Experimental group

Description:

0.003% AR-15512 ophthalmic solution, one drop in each eye twice a day for 365 days

Treatment:

Drug: 0.003% AR-15512 ophthalmic solution

AR-15512 Vehicle

Placebo Comparator group

Description:

AR-15512 vehicle ophthalmic solution, one drop in each eye twice a day for 365 days

Treatment:

Drug: AR-15512 vehicle ophthalmic solution